Kornimate/medical-research-clean huggingface dataset:
multifunctional magnetic resonance imaging in predicting breast lesions in women undergoing mastectomy for breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as multifunctional magnetic resonance imaging, may help doctors learn the extent of disease and plan the best treatment. purpose: this clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.

objectives: * to determine the accuracy of multifunctional magnetic resonance (mr) in detecting, localizing, and characterizing satellite lesions in relation to an index breast tumor in order to improve definition of clinical target volume after local excision. outline: patients receive an injection of gadolinium chelate and undergo multifunctional magnetic resonance (mr) imaging, including dynamic contrast-enhanced mr, hydrogen-mr spectroscopy, and diffusion-weighted mri, of the ipsilateral breast within 4 weeks before surgery. patients undergo a mastectomy as planned. the resected specimen is photographed, and a histopathological analysis is performed consisting of the size and grade (if pre-invasive or invasive disease) of each satellite lesion, classification of benign satellite lesions, dimensions of each lesion, distance from the edge of the index tumor to the center of each satellite lesion, and the distance from the center of the surface of the nipple to the center of each lesion.

Eligibility criteria:
disease characteristics: * biopsy-confirmed invasive ductal carcinoma of the breast * unifocal disease as defined by clinical examination, mammography, and ultrasound * patient must be proceeding to mastectomy * hormone receptor status unknown * no t4d or multifocal disease (as defined on conventional imaging) * index tumor ≤ 4 cm in diameter patient characteristics: * menopausal status not specified * female * no claustrophobia * no cup size of dd or greater prior concurrent therapy: * no prior surgery to ipsilateral breast * no prior neoadjuvant chemotherapy * no prior ferromagnetic implants

Keywords: invasive ductal breast carcinoma stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
safety and efficacy of atiprimod for patients with refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase i/iia clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.

this is a multi-center, open-label, dose escalation study intended to identify the mtd of atiprimod alone and the mtd of atiprimod when given in combination with ursodiol. the atiprimod dose will be escalated in sequential cohorts. ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. the dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). up to 105 patients will participate depending on the level at which toxicity is observed. patients will be assigned to dose level in the order of study entry.

Eligibility criteria:
inclusion criteria: * documented history of multiple myeloma, * failed at least two prior regimens for multiple myeloma, * 18 years of age or older, * ecog(zubrod)ps of 0 to 2, * screening evaluation for determining eligibility prior to enrollment, * signed informed consent form, exclusion criteria: * concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma , * renal insufficiency (serum creatinine levels of \> 2mg/dl), * mucosal bleeding, * any condition which in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study. * clinically relevant active infection or co-morbid medical conditions. * prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years. * patients with non-secretory myeloma. * as atiprimod is a potent inhibitor or cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.

Keywords: multiple myeloma
gynecological symptoms and health-related quality of life in egyptian women with sle

Conditions: SLE; Menstrual Irregularity

Summary: the purpose of our study was to recognize gynecological symptoms and health-related quality of life in egyptian women with systemic lupus erythematosus and evaluate the impact of duration of remission on qol in sle patients.

despite significant advances in recent decades, systemic lupus erythematosus (sle) is still burdened by irreversible organ damage and a notable impact on health-related quality of life (hrqol). improving the quality of life is a pivotal goal in the management of sle. according to the treat to target (t2t) recommendations for sle management, particular attention needs to be paid to the factors that negatively influence hrqol such as fatigue, pain and depression. recent epidemiological studies demonstrate that prolonged remission is an achievable target in sle patients and is clearly associated with better outcomes in terms of damage accrual. such findings also raise questions about the possible impact of remission on hrqol. in a retrospective study, patients in prolonged remission reported significantly better hrqol as assessed by the 36-item short-form health survey (sf36) and lupus pro questionnaire. methodology in details l: 70 women with sle will be included in this study from the outpatient clinic. in fayoum university hospital it will be conducted in the department of obstetrics and gynecology, fayoum university maternity hospital, egypt. full history taking (age, duration of marriage, parity, occupation, mode of delivery, history of abortion, medical and surgical history). menstrual histories obtained from participants included: age at menarche, duration of heavy bleeding, duration of menses and menstrual cycle, and other gynecological symptoms as questionnaire form. patients' blood pressure, height, weight, body mass index (bmi), and other clinical parameters were reviewed by the attending doctors. the patient's medications, which included immunosuppressive therapy such as steroids, cyclophosphamide, azathioprine, and cyclosporine a, where noted, and the use of other adjunctive medications were also recorded. definition of remission definition of remission was in line with european consensus criteria . clinical remission (clr) was present when clinical sledai score=0 and physician global score less than 0.5

Eligibility criteria:
inclusion criteria: 1. patients fulfilling the american college of rheumatology (acr) 1982 revised criteria for sle, 2. age between 15 and 55 years 3. and consented to the interview. exclusion criteria: 1. patients with active malignancy 2. and end-stage lupus nephritis 3. patients who had been treated with belimumab in the last 7 years, due to the reported effects of belimumab on hrqol.

Keywords: sle menstrual irregularity quality of life
evaluation of nutrition and metabolism in breast cancer patients

Conditions: Breast Cancer

Summary: with the increased success in breast cancer therapies, survivors develop unhealthy changes in body composition, such as muscle loss and fat gains, which lead to increased risk of cardiovascular disease and diabetes in survivorship. this study will examine the effects of a nutrition, cardiovascular and strength exercise program compared with a yoga program (representing usual care) on body composition and metabolism in recently diagnosed breast cancer patients. nutrition and exercise may improve various body composition and metabolic parameters, which may improve quality of life in survivorship, reduce risk of recurrence and reduce the risk of developing cardiovascular disease and diabetes in survivorship.

despite the increased success of novel anti-neoplastic therapies, breast cancer patients receiving chemotherapy develop unfavourable changes in body composition, including lean tissue loss and fat gains (1,2). these detrimental changes associate with poor quality of life (3,4) and may lead to treatment complications (5,6) during the cancer trajectory. in non-malignant populations, fat gain and muscle loss associate with increased risk of cardiovascular disease and diabetes (7). cancer survivors who gain fat and lose lean mass are not only predisposed to these diseases but also have an increased risk of cancer recurrence (3). proper nutrition as well as exercise can independently improve metabolic profiles (i.e. immune function, lipid and glucose metabolism) and overall health outcomes in non-malignant populations (7-9). while exercise has enhanced quality of life in breast cancer patients (4), overall nutritional needs and the metabolic benefits of exercise are unclear in this patient group. understanding the effects of nutrition and exercise interventions in breast cancer patients will form the basis for future studies and programs that integrate nutrition, exercise, and metabolism to reduce cancer recurrence and other morbidities in survivorship. this study will examine the effects of nutrition and exercise intervention on body composition and metabolism in recently diagnosed breast cancer patients.

Eligibility criteria:
inclusion criteria: * females 18 years old or older * recent diagnosis of breast cancer and up to 4 weeks following the first cycle of chemotherapy or up to the first 4 weeks of radiation therapy * clinical stages i-iiia * able to communicate freely in english * have sufficient cognitive ability to participate and provide informed consent exclusion criteria: * any known diagnosis of cardiovascular disease and thyroid disease that is not currently managed with medication or other therapies * any known diagnosis of diabetes or hiv * pre-existing injuries or health conditions that prevents the patient's safe participation in exercise * any previous diagnosis of cancer within the last 5 years (other than carcinoma in situ) * fasting glucose \>7.0 mm at baseline of the study * pregnant individuals will be excluded from this study
improving thoracic surgical care using electronic patient-reported outcomes (epros)

Conditions: Thoracic

Summary: this is a single-site, non-randomized study on the outcomes of remote real-time "epro monitoring" in thoracic surgery patients. epro monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (epro) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.

thoracic surgery patients are at high risk for severe complications post-surgery, such as respiratory failure, empyema, wound problems, and even mortality. patients with complications may need readmission and invasive management. usual care may not capture the symptoms of surgery complications. well-designed remote monitoring of postoperative patients may enable early intervention and lower the risk of severe complications. this study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (epros) monitoring in thoracic surgery patients. previous studies demonstrated the feasibility of epros monitoring by thoracic surgery patients and providers. this study will explore barriers to implementation before real-world effectiveness studies.

Eligibility criteria:
inclusion criteria: patients participating in epro monitoring must meet the following inclusion criteria to participate in this study: 1. 18 years or older 2. english or spanish speaking 3. able to complete a web-based, telephonic (ivr), or cra (or other irb-approved research team member)-administrated symptom survey 4. planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission) or been discharged from thoracic surgery within the last 30 days from or by thoracic surgery service. exclusion criteria: all patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation: 1. not completing planned surgery within 3 months of obtaining informed consent 2. inability to understand english or spanish 3. having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy) 4. dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent. 5. current incarceration 6. pregnancy

Keywords: electronic patient-reported outcome patient-reported outcome thoracic surgery complications
mobility hypertension management study

Conditions: Hypertension

Summary: the present prospective study aims to assess the efficacy of using the telehealth solution "hypertension monitor" in patients with hypertension by comparison to the standard care.

although, meta-analysis confirms that bp telemonitoring may represent a useful tool to improve hypertension management, the strength of the provided evidence is limited. therefore, future well-designed, large-sample, prospective, controlled trials are mandatory to understand the benefit of bp telemonitoring. recently, a specific telehealth solution for hypertension management has been developed in france (hypertension monitor - e-corelab®). the present prospective study aims to assess the efficacy of using the telehealth solution "hypertension monitor" in patients with hypertension by comparison to the standard care. the primary objective: to evaluate whether a home telehealth system can improve bp control and other risk factors in hypertensive individuals, as compared to the standard care.

Eligibility criteria:
inclusion criteria: * men or women * age between 18 and 80 years * patients with essential moderate hypertension * untreated or not adequately treated (need for treatment changes) * given written informed consent exclusion criteria: * severe hypertension (\>180/110 mmhg) * difficulties to perform home blood pressure measurements * patients with arm circumference \> 42 cm * night shift workers * body mass index \> 35 kg/m² * atrial fibrillation and/or another arrhythmia * pregnancy * cardiovascular events (stroke, myocardial infarction) in the last 6 months * severe sleep apnea syndrome

Keywords: hypertension telemonitoring digital health
genetic and epigenetic variations in heterokaryotypic monozygotic twins discordant for down syndrome

Conditions: Down Syndrome

Summary: heterokaryotypic monozygotic twins discordant for down syndrome (ds) are very rare, with an incidence estimated to be less than 1 over 7,000,000 pregnancy in the general population. sharing the same genetic patrimony, except for an additional chromosome 21 for one of them, any gene-expression difference between them could be attributed only to the supernumerary chromosome 21 and not to polymorphic variability in the rest of the genome. the setting up of a prospective longitudinal study will offer the major advantage of allowing genetic and epigenetic comparisons between them and to obtain important information on the impact of the environment in which they live and grow up.

it is planned to perform multi-omics analyses in order to reach an integrated understanding of the effect of genomic changes on protein expression, on biochemical posttranslational modifications of the synthetized proteins and on the modulation of some signalling pathways. this study will also allow the generation of induced pluripotent stem cells (ipscs) from blood cells and fibroblasts of the monozygotic twins useful as in-vitro models to study the pathogenesis and the pathophysiology of down syndrome. all this may shed the light on new research approaches in down syndrome. at last, the human gut microbiome, referring to the total microbial population in the human gastrointestinal tract, although thought to have its own impact, will also be studied. the microbiome is known to play a crucial role mainly in protecting the host against pathogenic microbes, modulating immunity, regulating metabolic processes, and controlling neuropsychiatric behaviour

Eligibility criteria:
inclusion criteria: * twins of a heterokaryotypic monozygotic pair discordant for ds * twins of a sex- and class of age-matched dizygotic pair discordant for ds, * sex- and class of age-matched patient with mosaic t21 * subject's parents/legal representatives willing to give written informed consent. * subject and his/her parents/legal representatives must be able/willing to comply with the protocol. * subject covered by social welfare. exclusion criteria: * none
evaluating a single-session mental health intervention for uk university students

Conditions: Depression; Anxiety; Happiness

Summary: the investigators are evaluating if an online single-session intervention, the common elements toolbox (comet) can improve mental health and wellbeing among uk university students.


Eligibility criteria:
inclusion criteria: * at least 18 years old exclusion criteria: -
intradermal injection of anti-ctla-4 in patients with stage i/ii melanoma

Conditions: Cutaneous Melanoma

Summary: this study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage i/ii melanoma patients undergoing a sentinel node biopsy (snb). patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab.

although of limited therapeutic value, the sln procedure has proven a useful prognostic tool for the assessment of melanoma relapse and mortality risk. moreover, the sln is of great value for the assessment of immunological interventions for melanoma. since early melanoma development is accompanied by impaired immune effector functions primarily in the sln, there is a strong rationale for therapeutic immune modulation of the sln aimed at strengthening cellular immune functions. the investigator now propose a phase i dose escalation study to administer intradermally a single clinical dose of tremelimumab/anti-ctla-4 locally at the primary tumor excision site of patients with clinical stage i/ii melanoma. such a single local administration aimed at conditioning of the sln should allow for the use of relatively low anti-ctla-4 dosages without excess risk of autoimmune effects.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * clinical stage i/ii melanoma patients, planned to undergo a sentinel lymph node biopsy (snb) * ecog performance status 0 or 1 * white blood count (wbc) ≥ 3 x10\^9/l * platelet count ≥ 100 x10\^9/l * hemoglobin ≥ 6.5 mmol/l * serum creatinine ≤ 2.5 x uln * total serum bilirubin, ast, alt and ldh ≤ 2x uln exclusion criteria: * non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab * prior treatment with a cd137 agonist or ctla-4 inhibitor or agonist * uncontrolled infectious disease including negative testing for hiv, hbv, hcv * autoimmune disease

Keywords: stage i-ii melanoma anti-ctla-4 immunotherapy neoadjuvant
interferon ß-1b treatment by cyclical administration

Conditions: Multiple Sclerosis

Summary: the therapy with interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. the 8 mui dose at alternate days is kept constant for years. about 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. the main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. there is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. this might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.


Eligibility criteria:
inclusion criteria: * patients affected by remitting multiple sclerosis who had at least a relapse in the last year of the disease. * satisfying general clinical conditions according to the researcher. adequate hepatic function. capacity to use adequate contraceptive techniques during the study. exclusion criteria: * any other disease that might better explain signs and symptoms of the patient. * any other disability condition that might interfere with the clinical evolution. * history of hypersensitivity to natural or recombinant interferon or to human albumin. * clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure. * not adequately controlled epilepsy. * inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study. * previous therapies modifying the disease course in the last six months. * steroid therapies in the last 3 months. * pregnancy, lactation, serological positivity to the pregnancy test during the screening period.

Keywords: multiple sclerosis interferon-ß-1b therapy
project pair: parent-implemented articulation intervention with recast

Conditions: Hearing Impaired Children

Summary: using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented broad treatment speech recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children. to address these objectives, the following research questions will be investigated: 1. does drill-based articulation therapy, administered by a speech-language pathologist, improve speech sound production in dhh children when parent-implemented btsr is concurrently utilized at home? 2. does the combination of parent-implemented btsr and clinician-led traditional articulation therapy result in generalization of speech sound accuracy at the conversation level?


Eligibility criteria:
inclusion criteria: * age 4;0-9;11 * permanent, prelingual sensorineural hearing loss * uses spoken english as their primary home language (≥ 51% of the time) * standard score ≥70 on the leiter * standard score ≥70 on the owls-ii listening comprehension * at least two speech sound errors appropriate to target based on speech norms and general stimulability exclusion criteria: * motor speech disorder (e.g., childhood apraxia of speech) * oral structural functional disorder (e.g., cleft palate) * diagnosis of autism spectrum disorder * diagnosis of adhd * uncorrected vision impairment (i.e., identified vision loss without the use of corrective lenses)

Keywords: deaf and hard of hearing articulation speech sound production parent training children